Novopharm Ltd
⚠️ Moderate Risk
FEI: 3005553197 • Torontotoronto, ONTARIO • CANADA
FEI Number
3005553197
Location
Torontotoronto, ONTARIO
Country
CANADAAddress
300 Novopharm Ct, , Torontotoronto, ONTARIO, Canada
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/27/2016 | 61TCY31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/20/2015 | 62LCA40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/5/2006 | 62OCA34FOSINOPRIL SODIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/26/2006 | 61JCA10FLUVASTATIN SODIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/26/2006 | 61NCA60TRAZODONE HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Novopharm Ltd's FDA import refusal history?
Novopharm Ltd (FEI: 3005553197) has 5 FDA import refusal record(s) in our database, spanning from 6/26/2006 to 1/27/2016.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Novopharm Ltd's FEI number is 3005553197.
What types of violations has Novopharm Ltd received?
Novopharm Ltd has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Novopharm Ltd come from?
All FDA import refusal data for Novopharm Ltd is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.